Genetic Biomarkers in Saliva Samples From Patients With Ewing Sarcoma

Children's Oncology Group

Status: Completed

Conditions: Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)

Treatments: Other: laboratory biomarker analysis; Other: questionnaire administration

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01876303

AEPI10N5 (Other Identifier)

U10CA098543 (U.S. NIH Grant/Contract)

NCI-2012-02210 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies genetic biomarkers from saliva samples in patients with Ewing sarcoma. Studying samples of saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Full description

PRIMARY OBJECTIVES:

I. To determine the association between the length of Ewing sarcoma breakpoint region 1-Friend leukemia virus integration 1 (EWS-FLI1) fusion protein binding sites (microsatellites) and risk of Ewing's sarcoma (ES).

II. To determine the frequency and commonality of Caucasian ancestral markers in cases of ES self-identified as non-Caucasian (African-American, Asian, Hispanic).

III. To determine the association between genomic variants in ES-related genes and hernia development (i.e. the integrin signaling pathway) and risk of ES.

OUTLINE:

Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Enrollment: 1,650 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The patient is enrolled on ACCRN07
• The patient has a diagnosis of Ewing Sarcoma (International Classification of Diseases [ICD] code morphology 9260; topography C40.0-C41.9, C76.0-C76.8, C80.9) and is registered with Children's Oncology Group (COG) by a North American member institution
• The patient must be diagnosed with Ewing sarcoma between December 24, 2007 and December 31, 2015
• The patient must have at least one biological parent alive and willing to participate
• All questionnaire respondents must understand English or Spanish
• Concomitant treatment on a therapeutic trial is not required

Trial design

1,650 participants in 1 patient group

Ancillary-Correlative (genetic epidemiology of Ewing sarcoma)

Description:

Genomic DNA is extracted from participants' saliva samples and analyzed for expression of EWS-FLI1 and other ES-target genes.

Treatment:

Other: questionnaire administration

Other: laboratory biomarker analysis